What is deferasirox?

Deferasirox is used to treat iron overload caused by blood transfusions in adults and children at least 2 years old.

Deferasirox is also used to treat chronic iron overload syndrome caused by a genetic blood disorder in adults and children who are at least 10 years old.

Deferasirox may also be used for purposes not listed in this medication guide.

What is the most important information I should know about deferasirox?

You should not use this medicine if you have severe kidney or liver disease, advanced cancer, a blood cell or bone marrow disorder, or low levels of platelets in your blood.

Deferasirox can harm your liver or kidneys. Stop using deferasirox and call your doctor at once if you have swelling, rapid weight gain, shortness of breath, pain in your upper stomach, loss of appetite, pain in your side or lower back, little or no urinating, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

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Deferasirox may also cause stomach or intestinal bleeding. Call your doctor at once if you have symptoms of stomach bleeding such as bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

What should I discuss with my healthcare provider before using deferasirox?

You should not use this medication if you are allergic to it, or if you have:

severe liver or kidney disease;

advanced cancer;

a bone marrow disorder; or

low levels of platelets in your blood.

To make sure deferasirox is safe for you, tell your doctor if you have:

kidney disease;

liver disease;

anemia (low red blood cells);

cancer (especially blood cell cancer such as leukemia);

a stomach ulcer;

a history of stomach or intestinal bleeding;

vision or hearing problems; or

a weak immune system caused by disease (such as cancer, HIV, or AIDS), or by receiving steroids, chemotherapy, or radiation.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Deferasirox can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

It is not known whether deferasirox passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking deferasirox.

How should I take deferasirox?

Your doctor may perform certain tests to make sure you do not have conditions that would prevent you from safely using deferasirox.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine at the same time every day.

Take Exjade on an empty stomach at least 30 minutes before eating.

You may take Jadenu on an empty stomach or with a small low-fat meal.

Do not chew, crush, or swallow the Exjade dispersible tablet whole. Place the Exjade tablet into a glass of apple juice, orange juice, or water and allow the tablet to disperse in the liquid. The tablet will not dissolve completely. Drink this mixture right away. To make sure you get the entire dose, add a little more liquid to the same glass, swirl gently and drink right away.

If you take less than 1000 milligrams (1 gram) daily, dissolve the Exjade tablets in about one-half cup of apple juice, orange juice, or water. If you take more than 1000 milligrams daily, dissolve the tablets in about 1 cup of apple juice, orange juice, or water.

While using deferasirox, you may need frequent blood tests. Your kidney or liver function may also need to be checked every 6 months, and you may need a liver biopsy.

Store at room temperature, away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking deferasirox?

Do not use other iron-chelating medicines such as deferoxamine (Desferal), unless your doctor has told you to.

While you are taking deferasirox, do not take antacids that contain aluminum, such as Amphojel, Gaviscon, Maalox, Mi-Acid, Mylanta, Rulox, and others.

Deferasirox may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Deferasirox side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using deferasirox and call your doctor at once if you have:

problems with vision or hearing;

kidney problems--urinating more or less than usual; painful or difficult urination; swelling in your feet or ankles; weakness, bone pain; feeling tired or short of breath;

severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Serious side effects may be more likely in older adults.

Common side effects may include:

nausea, vomiting, stomach pain;

diarrhea; or

skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Comments: Deferasirox therapy should only be considered when a patient with a non-transfusion dependent thalassemia syndrome has a liver iron concentration (LIC) of at least 5 mg of iron per gram of liver dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L.

Prior to starting therapy, obtain:-LIC by liver biopsy or by an FDA-cleared or approved method for identifying patients for treatment with deferasirox therapy-Serum ferritin level on at least 2 measurements one month apart-Baseline serum creatinine in duplicate (due to variations in measurements) and determine the creatinine clearance (Cockcroft-Gault method) -Serum transaminases and bilirubin-Baseline auditory and ophthalmic examinations

Dose Adjustments:-If the baseline LIC is greater than 15 mg Fe/g dw, consider increasing the dose to 20 mg/kg/day after 4 weeks.-Monitor serum ferritin monthly. -Interrupt treatment when serum ferritin is less than 300 mcg/L and obtain an LIC to determine whether the LIC has fallen to less than 3 mg Fe/g dw.-Monitor LIC every 6 months.-After 6 months of therapy, if the LIC remains greater than 7 mg Fe/g dw, increase the dose of deferasirox to a maximum of 20 mg/kg/day. Do not exceed a maximum of 20 mg/kg/day.-If after 6 months of therapy, the LIC is 3-7 mg Fe/g dw, continue treatment with deferasirox at no more than 10 mg/kg/day.-When the LIC is less than 3 mg Fe/g dw, interrupt treatment with deferasirox and continue to monitor the LIC.-Monitor blood counts, hepatic function, and renal function.-Restart treatment when the LIC rises again to more than 5 mg Fe/g dw.

Comments: Deferasirox therapy should only be considered when a patient with a non-transfusion dependent thalassemia syndrome has a liver iron concentration (LIC) of at least 5 mg of iron per gram of liver dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L.

Prior to starting therapy, obtain:-LIC by liver biopsy or by an FDA-cleared or approved method for identifying patients for treatment with deferasirox therapy-Serum ferritin level on at least 2 measurements one month apart-Baseline serum creatinine in duplicate (due to variations in measurements) and determine the creatinine clearance (Cockcroft-Gault method) -Serum transaminases and bilirubin-Baseline auditory and ophthalmic examinations

Dose Adjustments:-If the baseline LIC is greater than 15 mg Fe/g dw, consider increasing the dose to 20 mg/kg/day after 4 weeks.-Monitor serum ferritin monthly. -Interrupt treatment when serum ferritin is less than 300 mcg/L and obtain an LIC to determine whether the LIC has fallen to less than 3 mg Fe/g dw.-Monitor LIC every 6 months.-After 6 months of therapy, if the LIC remains greater than 7 mg Fe/g dw, increase the dose of deferasirox to a maximum of 20 mg/kg/day. Do not exceed a maximum of 20 mg/kg/day.-If after 6 months of therapy, the LIC is 3-7 mg Fe/g dw, continue treatment with deferasirox at no more than 10 mg/kg/day.-When the LIC is less than 3 mg Fe/g dw, interrupt treatment with deferasirox and continue to monitor the LIC.-Monitor blood counts, hepatic function, and renal function.-Restart treatment when the LIC rises again to more than 5 mg Fe/g dw.

What other drugs will affect deferasirox?

Many other medicines can increase or decrease the effects of deferasirox. Tell your doctor about all your current medicines and any you start or stop using, especially:

This list is not complete. Other drugs may interact with deferasirox, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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Where can I get more information?

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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